NCT00023816

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of carbendazim in treating patients who have advanced solid tumors or lymphoma.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2001

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

April 5, 2004

Completed
Last Updated

September 20, 2013

Status Verified

December 1, 2001

First QC Date

September 13, 2001

Last Update Submit

September 19, 2013

Conditions

LymphomaUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage IV adult Hodgkin lymphomarecurrent adult Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomaunspecified adult solid tumor, protocol specificstage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomaprimary central nervous system non-Hodgkin lymphomaAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomaintraocular lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomaanaplastic large cell lymphomastage IV mycosis fungoides/Sezary syndromerecurrent mycosis fungoides/Sezary syndromerecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

carbendazimDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor for which no standard therapy exists or which has progressed or recurred after prior therapy OR Lymphoma for which no further therapeutic options exist No hematological malignancies (e.g., leukemia) No known brain or leptomeningeal disease unless previously treated with radiotherapy, not currently treated with corticosteroid therapy, and no clinical symptoms present PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL AST or ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if due to tumor involvement) Alkaline phosphatase less than 2.5 times ULN Renal: Creatinine no greater than 2 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No unstable atrial or ventricular arrhythmias that require control by medication No ischemic event within the past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Abnormalities that would affect absorption of study drug allowed at investigator's discretion No other severe disease or psychiatric disorder that would preclude study No phenylketonuria No known hypersensitivity reaction to artificial sweetener aspartame (e.g., Nutrasweet) PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Recovered from prior chemotherapy for cancer No other concurrent cytotoxic therapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics Recovered from prior radiotherapy for cancer Surgery: Recovered from prior surgery for cancer Prior gastrointestinal surgery allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

LymphomaHodgkin DiseaseLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaIntraocular LymphomaLymphoma, Mantle-CellLymphoma, Large-Cell, AnaplasticMycosis FungoidesSezary SyndromeLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

carbendazim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsEye NeoplasmsNeoplasms by SiteLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lee S. Rosen, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2001

First Posted

April 5, 2004

Last Updated

September 20, 2013

Record last verified: 2001-12